Financial Performance - For the nine months ended September 30, 2024, the Company recorded a net loss of $2,968,271 and used cash in operations of $2,565,861[236]. - The net loss for the three months ended September 30, 2024 was $986,030, compared to a net loss of $1,018,760 for the same period in 2023[305]. - The company incurred a net loss of $2,968,271 for the nine months ended September 30, 2024, an improvement from a net loss of $4,054,774 for the same period in 2023[318]. - General and administrative costs for the three months ended September 30, 2024 were $621,627, a decrease of $270,067 or 30.3% compared to $891,694 in 2023[293][295]. - For the nine months ended September 30, 2024, general and administrative costs were $2,267,890, a decrease of $1,047,407 or 31.6% compared to $3,315,297 in 2023[307][309]. - Research and development costs for the three months ended September 30, 2024 were $361,630, an increase of $229,143 or 173.0% compared to $132,487 in 2023[296][303]. - Research and development costs for the nine months ended September 30, 2024 were $691,402, a decrease from $749,029 in 2023[310][312]. - The Company had no revenues for the three months ended September 30, 2024 and 2023[292]. Cash and Funding - At September 30, 2024, the Company had cash of $1,637,627 available to fund its operations[236]. - The Company estimates that its existing cash resources will fund the current clinical trial program through the first quarter of 2025[241]. - The company estimates that its existing cash resources will fund its current clinical trial program through the first quarter of 2025, but additional capital will be needed for further development[322]. - The Company is considering various strategies to obtain additional capital due to uncertainty in market conditions[242]. - The Company is exploring various strategies to raise additional capital to fund its ongoing research and development activities[321]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor with clinical anti-cancer activity at low toxicity[233]. - LB-100 is currently in clinical trials for Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable Colon Cancer, and Advanced Soft Tissue Sarcoma, showing anti-cancer activity in various animal models[273]. - The Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute on June 10, 2024, for a Phase 1b/2 clinical trial of LB-100 combined with atezolizumab[299][313]. - The Company announced a Phase 1b/2 clinical trial at MD Anderson Cancer Center to assess LB-100 combined with GSK's dostarlimab-gxly for ovarian clear cell carcinoma, with completion expected by December 31, 2027[350]. - The Phase 1 portion of the trial began in Q2 2023, with a median progression-free survival (PFS) of 4.5 months for doxorubicin alone and 7.5 months for the combination therapy expected[341]. - The interim analysis of the Phase 2 trial will assess the potential superiority of LB-100 plus doxorubicin over doxorubicin alone, which could change the standard therapy for advanced soft tissue sarcoma[346]. Patent and Licensing - The Company received a Notice of Allowance from the USPTO for a patent application related to combining LB-100 with innovative cancer immunotherapies[235]. - The Company has filed patent applications for LB-100 in the U.S. and internationally, with patents issued in multiple countries including the U.S., Mexico, and Japan[277]. - The Company appointed a new President and CEO in September 2023 to analyze its patent portfolio and balance prosecution costs with protection benefits[265]. - The Company plans to discontinue support for certain patent filings starting in 2024, while continuing to develop its patent portfolio related to LB-100[265]. - The Company entered into a Patent License Agreement with NIH effective February 23, 2024, focusing on anti-cancer activity, with an estimated duration of twenty years[369]. - The Company is obligated to pay NIH a non-refundable license issue royalty of $50,000 and a first minimum annual royalty of $25,643, with subsequent annual royalties of $30,000 due each January 1[371]. - The License Agreement includes four benchmarks with a total payment obligation of $1,225,000, the first benchmark payment of $100,000 due by October 1, 2024[373]. Operational Risks - The Company faces risks related to serious adverse events in clinical trials, which could lead to regulatory holds and impact development timelines[281]. - The Company is monitoring potential impacts from geopolitical risks, inflation, and supply chain issues on its operations and financial performance[288]. - Cybersecurity risks are assessed regularly, with no significant challenges reported that have impaired operations or financial condition[289]. - The Company faces uncertainties in research and development, with no assurance of sufficient cash position to develop pharmaceutical compounds for future revenues[391]. Commitments and Agreements - The Company's remaining financial contractual commitments pursuant to clinical trial agreements not yet incurred aggregated approximately $3,918,000, scheduled to be incurred through approximately December 31, 2027[236]. - The aggregate commitment under the agreement with GEIS, as of September 30, 2024, totaled approximately $3,616,000, scheduled to be incurred through December 31, 2027[349]. - The Company's aggregate commitment under the Development Collaboration Agreement with NKI, as of September 30, 2024, totaled approximately $279,000, expected to be incurred through October 8, 2026[388].
Lixte Biotechnology(LIXT) - 2024 Q3 - Quarterly Report